Trial Outcomes & Findings for Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial. (NCT NCT03296553)
NCT ID: NCT03296553
Last Updated: 2022-01-27
Results Overview
We measured the number of patients who died of IRIS-KS following the definition of IRIS-KS that is specified in the protocol.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
48 weeks
Results posted on
2022-01-27
Participant Flow
Participant milestones
| Measure |
Valganciclovir
Oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antirretroviral therapy) until suppression of HHV-8.
Valganciclovir: The experimental group will receive Valganciclovir 900 mg twice in a day before the initiation of cART until viral load of HHV-8 is undetectable.
20 experimental included 2 eliminated
18 patients included finally.
|
Antiretroviral Combinations
Standard treatment with cART according to current HIV Therapy Mexican guidelines.
Antiretroviral Combinations: Patients will receive standard antiretroviral treatment as recommended
20 control patients included
1 eliminated
19 patients included finally
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Valganciclovir
Oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antirretroviral therapy) until suppression of HHV-8.
Valganciclovir: The experimental group will receive Valganciclovir 900 mg twice in a day before the initiation of cART until viral load of HHV-8 is undetectable.
20 experimental included 2 eliminated
18 patients included finally.
|
Antiretroviral Combinations
Standard treatment with cART according to current HIV Therapy Mexican guidelines.
Antiretroviral Combinations: Patients will receive standard antiretroviral treatment as recommended
20 control patients included
1 eliminated
19 patients included finally
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.
Baseline characteristics by cohort
| Measure |
Valganciclovir
n=20 Participants
Patients in this group received oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antiretroviral therapy) until suppression of HHV-8 viral load.
|
Combined Antiretroviral Treatment
n=20 Participants
Patients in this group started standard treatment with cART (combined antiretrovrial therapy) according to current HIV Therapy Mexican guidelines.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
n=39 Participants
|
31 years
n=41 Participants
|
31 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Patients assigned to each study group
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 48 weeksWe measured the number of patients who died of IRIS-KS following the definition of IRIS-KS that is specified in the protocol.
Outcome measures
| Measure |
Valganciclovir
n=20 Participants
Oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antirretroviral therapy) until suppression of HHV-8.
Valganciclovir: The experimental group will receive Valganciclovir 900 mg twice in a day before the initiation of cART until viral load of HHV-8 is undetectable.
20 experimental included 2 eliminated
18 patients included finally.
|
Antiretroviral Combinations
n=20 Participants
Standard treatment with cART according to current HIV Therapy Mexican guidelines.
Antiretroviral Combinations: Patients will receive standard antiretroviral treatment as recommended
20 control patients included
1 eliminated
19 patients included finally
|
|---|---|---|
|
Number of Participants Who Died of Immune Reconstitution Inflammatory Syndrome Associated to Kaposi Sarcoma (IRIS-KS)
|
0 Participants
|
3 Participants
|
Adverse Events
Valganciclovir
Serious events: 0 serious events
Other events: 2 other events
Deaths: 3 deaths
Antiretroviral Combinations
Serious events: 0 serious events
Other events: 1 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Valganciclovir
n=18 participants at risk
Oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antirretroviral therapy) until suppression of HHV-8.
Valganciclovir: The experimental group will receive Valganciclovir 900 mg twice in a day before the initiation of cART until viral load of HHV-8 is undetectable.
20 experimental included 2 eliminated
18 patients included finally.
|
Antiretroviral Combinations
n=19 participants at risk
Standard treatment with cART according to current HIV Therapy Mexican guidelines.
Antiretroviral Combinations: Patients will receive standard antiretroviral treatment as recommended
20 control patients included
1 eliminated
19 patients included finally
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia <500 cell
|
11.1%
2/18 • Number of events 3 • 48 weeks
|
5.3%
1/19 • Number of events 2 • 48 weeks
|
Additional Information
Dr. Patricia Volkow
Instituto Nacional de Cancerología
Phone: 01 55 5628 0400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place